Importer of Controlled Substances Application: Fisher Clinical Services, Inc., 61248-61249 [2016-21240]

Download as PDF 61248 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 450 Fifth Street NW., Suite 7100 Washington, DC 20530 Telephone: (202) 598–2436 Facsimile: (202) 514–9033 Email: soyoung.choe@usdoj.gov mstockstill on DSK3G9T082PROD with NOTICES Certificate of Service I hereby certify that on this 29th day of August, 2016, the foregoing Notice of Extension of Time was filed using the Court’s CM/ECF system, which shall send notice to all counsel of record. lllll/s/lllll Soyoung Choe U.S. Department of Justice, Antitrust Division Networks & Technology Enforcement Section 450 Fifth Street NW., Suite 7100 Washington, DC 20530 Telephone: (202) 598–2436 Facsimile: (202) 514–9033 Email: soyoung.choe@usdoj.gov May 31, 2016 Via Federal Express United States Department of Justice 450 Fifth Street Suite 7100 Washington, DC 20530 Attn: Maribeth Petrizzi Chief Litigation II Section Antitrust Division Dear Sirs/Madam: Please accept these public comments from Robert S. Moran, Jr., the undersigned, a partner of the law firm of McBreen & Kopko in connection with the pending matter captioned United States vs. Iron Mountain Inc. (‘‘Iron Mountain’’) and Recall Holdings Ltd. (‘‘Recall’’); Proposed Final Judgment and Competitive Impact Statement Civil Action No. 1–16–cv–00595. Please be advised that the undersigned represents National Records Centers, Inc. (‘‘NRC’’) a nationwide provider of records management services (‘‘RMS’’) throughout the United States. NRC competes directly with Iron Mountain, Recall and Access CIG, LLC (‘‘Access’’) in many markets. It is our position that the proposed acquisition will have an anticompetitive effect and a detrimental impact on the customers of Iron Mountain, Recall and Access throughout the United States. NRC urges the Department of Justice to completely re-think the Iron Mountain/ Recall merger in its totality. Combining the number one company in the industry with the number two company is unfair and anticompetitive by its very nature. Approving such an anticompetitive combination of businesses by merely causing business number two to shed some of its business is clearly not enough to result in open and fair competition. Forcing divestiture VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 of this business to the number three company in the industry makes no sense at all. Instead of forcing this divestiture to a huge and growing company, the Department of Justice should just simply allow those customers affected by the merger out of their contracts, without penalty, should they chose to do so. Then those customers could pick their service provider by price and service and not be forced with the unhappy choice of staying with company two or going to company three. Customers are much better served with choices. The foundation of our pro-competition philosophy is choice. The Department of Justice should not engineer a Proposed Final Judgment that serves to limit customer choices. It is our further position that the Proposed Final Judgment requires changes, at a minimum, to make it more equitable and to address our anticompetitive concerns. First, we see no reason why any customer of Recall (not just a ‘‘Split-City Customer’’) should not have the right to terminate its contract with Recall without penalty. This is fair and reasonable. Second, the definition for ‘‘Split Multi-City Customer’’ is overly restrictive. The definition used in the Proposed Final Judgment contains the qualification that ‘‘a Split Multi-City Customer does not include a Recall customer that has separate contracts for each Recall facility in which it stores records’’. It is our belief that this qualifying statement should be deleted from the Split Multi-City Customer definition. In the Proposed Final Judgment Section IV ‘‘Divestitures’’, subparagraph J it is provided that for a period of one ( 1) year from the date of the sale of any Divestiture Assets to an Acquirer, defendant shall allow any Split MultiCity Customer to terminate or otherwise modify its contract with Recall so as to enable the Split Multi-City Customer to transfer some or all of its records to that Acquirer without penalty or delay and shall not enforce any contractual provision providing for permanent withdrawal fees, retrieval fees, or other fees associated with transferring such customers’ records from a Recall Management Facility to a facility operated by Acquirer’’. We see no reason why provision J does not allow that any Split Multi-City Customer can have the discretion to terminate or otherwise modify its contract with Recall so as to enable the Split Multi-City Customer to transfer some or all of its records to any other person or entity engaged in the records PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 management business and not solely to Access. In this way fair and open competition for the business of any Split Multi-City Customer would occur allowing either Access or any other service provider to win the business. The substantial benefit to any Split Multi-City Customer is obvious. To restrict the discretion of these Split Multi-City Customers so that they have to do business with Access is unfair and inequitable. Also the qualification to the definition of Split Multi-City Customer further has anti-competitive affects and restricts open and fair competition. It is our sincere hope that the acquisition of Recall by Iron Mountain not go forward. If it were to go forward then Recall customers in the affected markets should be free (without penalty) to choose any new service provider. Should the Department of Justice move forward with this Proposed Final Judgment, NRC strongly encourages the Department of Justice to modify the proposed Final Judgment in two ways. First, to delete the qualification to the definition of Split Multi-City Customer and second, to modify Provision IV Subsection J to enlarge the period from one (1) year to three (3) years and to allow any Split Multi-City Customer to terminate or otherwise modify its contract with Recall so as to enable the Split Multi-City Customer to transfer its records without penalty or delay to any records storage provider and not only to Access. The foregoing is submitted respectfully and in the interest of fair and open competition to enhance the opportunity for any records storage company to obtain the business that is being divested as part of this proposed Final Judgment. Thank you. Very truly yours, /s/ lllllllllllllllll Robert S. Moran, Jr. RSM:km [FR Doc. 2016–21287 Filed 9–2–16; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefor, may file written DATES: E:\FR\FM\06SEN1.SGM 06SEN1 61249 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before October 6, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 6, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on June 17, 2016, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of the following basic classes of controlled substances: mstockstill on DSK3G9T082PROD with NOTICES Controlled substance Schedule Methylphenidate (1724) ................ Levorphanol (9220) ...................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ II II II II The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of finished FDA approved or non-approved dosage form for VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Placement of this drug code onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–21240 Filed 9–2–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before November 7, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant SUPPLEMENTARY INFORMATION: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on May 18, 2016, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule I II II II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–21238 Filed 9–2–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Isosciences ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before November 7, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal DATES: E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61248-61249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21240]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fisher Clinical 
Services, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefor, may file written

[[Page 61249]]

comments on or objections to the issuance of the proposed registration 
in accordance with 21 CFR 1301.34(a) on or before October 6, 2016. Such 
persons may also file a written request for a hearing on the 
application pursuant to 21 CFR 1301.43 on or before October 6, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated her authority under the 
Controlled Substances Act to the Administrator of the Drug Enforcement 
Administration (DEA), 28 CFR 0.100(b). Authority to exercise all 
necessary functions with respect to the promulgation and implementation 
of 21 CFR part 1301, incident to the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances (other than final orders in connection with suspension, 
denial, or revocation of registration) has been redelegated to the 
Deputy Assistant Administrator of the DEA Office of Diversion Control 
(``Deputy Assistant Administrator'') pursuant to section 7 of 28 CFR 
part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on June 
17, 2016, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, 
Pennsylvania 18106 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Levorphanol (9220).........................  II
Noroxymorphone (9668)......................  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import the listed substances for analytical 
research, testing, and clinical trials. This authorization does not 
extend to the import of finished FDA approved or non-approved dosage 
form for commercial distribution in the United States.
    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. Placement of this drug code onto the company's registration 
does not translate into automatic approval of subsequent permit 
applications to import controlled substances. Approval of permit 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under to 21 U.S.C. 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-21240 Filed 9-2-16; 8:45 am]
 BILLING CODE 4410-09-P
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